Pharmaceutical particulars : מידע רוקחי

6.      PHARMACEUTICAL PARTICULARS
6.1     List of excipients

Sodium hydroxide (pH adjustment)
Phosphoric acid (pH adjustment)
Water for injections

6.2     Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3     Shelf life

.
The expiry date of the product is indicated on the packaging materials.

Once the vial is opened, the medicinal product should be used immediately.

6.4     Special precautions for storage
Do not store above 30°C.

Keep vial in the outer carton to protect from light.

6.5     Nature and contents of container
Glass vial with a fluoropolymer-coated rubber stopper and an aluminium overseal with a flip-off button. Each vial contains 0.5 mL solution for injection.

Pack size of one vial.

6.6     Special precautions for disposal and other handling
This medicinal product is ready-to-use and for single use only.

Instructions for use

For subcutaneous use only

•     Collect materials not included in the pack that are needed for administration which will include a sterile syringe (0.3 mL, 1 mL, or 3 mL), an 18-gauge (G) needle, and a 25-G to 31-G needle.
•     Calculate the required volume of Oxlumo based on the recommended weight-based dose. If the dose is more than 0.5 mL, you will need to use more than one vial. The maximum acceptable single injection volume to be administered is 1.5 mL. If more than 1.5 mL is needed, you may need to give more than one subcutaneous injection.
•     To withdraw Oxlumo, hold the vial upright or tilt at a slight angle and ensure the flat edge of the needle is pointed downwards.
•     Point the needle and syringe straight up and tap the syringe to move any bubbles to the top. Once the bubbles are at the top, gently push the plunger to force the bubbles out of the syringe. Check to ensure the correct amount of medicine is in the syringe.
•     Administer the medicine with a sterile 25- to 31-G needle with a 13-mm or 16-mm needle length for subcutaneous injection. For volumes less than 0.3 mL, a sterile 0.3-mL syringe is recommended.
•     Note: Do not push this medicine into the 25-G to 31-G needle. When using 0.3 mL (insulin) syringes, do not force the bubble from syringe.
•     Injection can be into the abdomen, upper arms, or thighs. Consider rotating injection sites. Do not administer into scar tissue or areas that are reddened, inflamed, or swollen.
•     Note: When administering subcutaneous injections into the abdomen, avoid a 2.0-cm diameter circle around the navel.
•     Clean the area of planned injection with an alcohol swab and wait for the area to dry completely.
•     Ensure proper injection technique. Do not inject into a vein or muscle.
•     Insert the needle at a right angle (90 degrees) to deliver the injection just below the skin. In patients with little subcutaneous tissue, the needle should be inserted at a 45-degree angle.
•     Do not press down on the plunger while piercing the skin. Once the needle is inserted through the skin, release the pinched skin and administer the dose in a slow and steady manner. Once the medicine has been administered count for at least 5 seconds before withdrawing the needle from the skin. Lightly press gauze or cotton ball on the injection site as needed. Do not put the needle cap back on.
•     Note: Do not aspirate after inserting the needle to prevent tissue damage, haematoma, and bruising.
•     If more than one injection is needed for a single dose of Oxlumo, the injection sites should be at least 2 cm apart.
•     Only use the vial once. After administering the dose, dispose of any unused medicine in the vial according to local regulations.
•     Use the syringes, transfer needles, and injection needles only once. Dispose of any used syringes and needles in accordance with local regulations.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.